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New treatment option for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Official title A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
ClinicalTrials.gov ID: NCT06108492
What this study is testing
What is SHR-2005?
SHR-2005 is an investigational medicine, being studied as a potential treatment for intermediate and high-risk non-muscle invasive bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must voluntarily agree to participate in the trial and sign a written informed consent form;
- ≥18 years of age, either sex;
- Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;
- ECOG performance status of 0-1;
- Life expectancy ≥ 2 years;
You likely can't join if
- Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;
- Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;
- History of serious cardiovascular and cerebrovascular diseases;
- Severe infection within 2 weeks prior to the first dose;
- Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;
- Oversize surgery or severe trauma within 4 weeks before the first use of research drugs;
See the full eligibility criteria
- people must voluntarily agree to participate in the trial and sign a written informed consent form;
- ≥18 years of age, either sex;
- Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;
- ECOG performance status of 0-1;
- Life expectancy ≥ 2 years;
- Adequate bone marrow and organ function.
- Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;
- Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;
- History of serious cardiovascular and cerebrovascular diseases;
- Severe infection within 2 weeks prior to the first dose;
- Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;
- Oversize surgery or severe trauma within 4 weeks before the first use of research drugs;
- Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.